Intravenous thrombolysis versus antiplatelet standard care for patients with mild acute ischemic stroke: a systematic review and meta-analysis

TL;DR

This study compares intravenous thrombolysis to standard antiplatelet treatment for mild stroke and finds no benefit with thrombolysis, which may increase risks.

Contribution

The study provides new evidence that IVT may not be beneficial and could be harmful for mild stroke compared to standard care.

Findings

IVT showed lower rates of functional independence compared to antiplatelet therapy.

IVT was associated with higher 90-day mortality and increased risk of sICH.

Outcomes had low heterogeneity across the analyzed trials.

Abstract

To evaluate the safety and efficacy of intravenous thrombolysis (IVT) versus standard antiplatelet therapy in patients with minor acute ischemic stroke (AIS).

A systematic review and meta-analysis of databases, including PubMed, Embase, Web of Science, and Cochrane Library, up to 27 June 2025. Inclusion criteria were randomized clinical trials comparing IVT with standard antiplatelet care in patients with mild acute ischemic stroke. Exclusions included non-randomized studies, observational studies, non-interventional trials, meeting abstracts, duplicates, studies with overlapping data, and non-English language studies. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Fixed-effects or random-effects model meta-analysis were used to analyze the pooled data. Main outcomes and measures: Rates of functional independence (modified Rankin Scale score ≤ 1 or ≤ 2), 90-day mortality, sICH.

Four randomized clinical trials, involving 3,405 initially enrolled patients, were included in the analysis. A lower rate of functional independence was observed in the IVT group (mRS ≤ 1, relative risk [RR], 0.97 [95% CI, 0.94–1.00]; mRS ≤ 2, RR, 0.97 [95% CI, 0.95–0.99]). Higher 90-day mortality rates (RR, 2.42 [95% CI, 1.39–4.20]) and sICH rates (RR, 4.90 [95% CI, 1.67–14.40]) were observed in the IVT group. All outcomes reported in this analysis had low heterogeneity.

Our findings suggest that intravenous thrombolysis for mild acute ischemic stroke yields no benefit and may pose additional risks compared to antiplatelets standard care. More large clinical randomized controlled trials are still needed in the future to validate our results.

[https://www.crd.york.ac.uk/prospero/], identifier [CRD42025643646].

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